1. Field of the Invention
The present invention relates to absorbent products and, in particular, to absorbent products such as tampons and similar catamenial devices. More particularly, the present invention relates to tampons and other catamenial devices that reduce or inhibit the amount of bacteria within the vagina coming into contact with the catamenial device.
2. Description of the Prior Art
Menstrually occurring toxic shock syndrome (TSS), a multi-system disease associated with colonization by Staphylococcus aureus (S. aureus) bacteria, has been associated with the use of tampons during menstruation. It is believed that the disease is caused by toxic shock syndrome toxin-1 (TSST-1). This toxin has been found to have been produced by Staphylococcal strains isolated from menstrual TSS patients.
Staphylococci may be present in the vagina or in the nose or the throat or on the skin. The blood, desquamated tissue and other materials present in the vagina during menstruation are a culture medium for S. aureus and organisms symbiotic to Staphylococci. As the Staphylococci increase in number, toxins may be produced that are absorbed through the vaginal wall, potentially resulting in toxic shock syndrome.
There have been numerous attempts to address toxic shock syndrome through modifications to catamenial devices, and specifically, catamenial tampons.
U.S. Pat. No. 4,405,323 to Auerbach is directed to a tampon designed to eliminate the hazards of toxic shock syndrome and dysmenorrhea. The tampon has incorporated therein an antibacterial agent. The agent allegedly disperses on contact with body fluids and prevents development of the organisms that produce the toxins, which cause toxic shock syndrome. Among the antibacterial materials disclosed for use are povidone-iodine compound, mercury, zinc, penicillin, erythromycin and nitrofurazone.
Patent Cooperation Treaty Publication No. WO 86/05388 (published Sep. 25, 1986) to Kass provides that the inclusion of a salt of a nontoxic divalent cation in absorptive pads, e.g. catamenial tampons, inhibits production of toxic shock syndrome toxin-1 and other staphylococcal products during use of said absorptive pad. Suitable salts include those of magnesium, barium, calcium or strontium (preferred) or of other divalent cations such as zinc, manganese, copper, iron, nickel and the like.
In U.S. Pat. No. 4,374,522 to Olevsky, it is stated that patterns of use of catamenial tampons seem to indicate that high absorptive capacity with the concomitant extended period of use of certain tampons are factors that contribute to the formation of toxic shock syndrome. The patent provides a tampon made of conventional cellulosic materials, such as rayon fibers, which have been compressed into a bullet-shape with an open bottom surface sealed by a fluid impermeable sheet. The fluid impermeable bottom and the traditional bullet shaped pledget define a hollow core, central reservoir area, which serves as a reservoir for excess menstrual fluid.
U.S. Pat. No. 4,431,427 to Lefren et al. discloses menstrual tampons comprising physiologically safe, water-soluble acids in their monomeric, oligomeric or polymeric forms. Citric, glycolic, malic, tartaric and lactic acids are disclosed as being useful in the practice of the invention. The presence of one or more of the above-noted acids in a tampon is said to inhibit the growth of bacteria responsible for toxic shock. Where an acid is used in its polymeric form, the tampon may additionally include an enzyme to hydrolyze the polymeric acid to its monomeric form.
Canadian Patent No. 1,123,155 to Sipos discloses a catamenial tampon for preventing toxic shock syndrome during menstrual flow. The body of the tampon, which is open at the insertion end and is closed at the withdrawal end, is snugly surrounded in its expanded condition by a fluid proof, thin and flexible membrane. This membrane, which can be made of polyethylene sheet, is biased against the vaginal wall during use of the tampon, is neutral to the vaginal mucosa and is completely impermeable to bacteria, viruses and toxic decomposition products of the menstrual flow.
Canadian Patent No. 1,192,701 to Bardhan discloses a tampon for the absorption of menstrual flow. The tampon comprises an inner layer of liquid-absorbent material and an outer layer, which surrounds and encloses the inner layer. Menstrual discharge may flow inwardly to the inner layer, but the outer layer is impervious to the passage of menstrual fluid outwardly from the inner layer. A plurality of liquid absorbent wicks extending from the inner layer through apertures formed in the outer layer serve as conduits for the flow of menstrual discharge from outside the tampon to the inner layer thereof. The disclosed structure allegedly minimizes the availability of discharge outside the tampon with a resulting reduction in the likelihood of growth of S. aureus and consequently its production of toxin. This patent also discloses that an antimicrobial compound, which is bactericidal or bacteriostatic to S. aureus, may be included in the inner layer. The antimicrobial agent may take the form of an antibiotic (such as penicillin, erythromycin, tetracycline or neomycin), a chemotherapeutic agent (such as a sulfonamide) or a disinfectant (such as phenol).
U.S. Pat. No. 4,585,792 to Jacob et al. discloses that L-ascorbic acid when topically applied to the vaginal area of a human female during manses will inactivate toxins known to contribute to Toxic Shock Syndrome. The ascorbic acid compound may be carried by a vaginal tampon. The disclosure of U.S. Pat. No. 4,722,937 is to the same effect.
U.S. Pat. No. 4,413,986 to Jacobs discloses a sterilely-packaged tampon assembly for sterile insertion of a tampon into the vagina and having a guide tube telescoped around an insertion tube and a flexible sheath attached to the inner end of the guide tube and tucked into the inner end of the insertion tube. In use, as the insertion tube is pushed through the guide tube and into the vagina, the flexible sheath is pulled over the inner end of the insertion tube and extends along the exterior thereof. The portion of the insertion tube, which is inserted into the vagina, is at all times fully sheathed by the flexible sheath.
U.S. Pat. Nos. 5,389,374, 5,547,985, 5,641,503, 5,679,369, 5,705,503, and 5,753,252, all to Brown-Skrobot et al., each disclose an absorbent product having a compound for inhibiting toxins produced by Staphylococcus aureus bacteria. The compound is selected from the group consisting of (1) monoesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms, in which the monoester has at least one hydroxyl group associated with its aliphatic alcohol residue, (2) diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms, in which the diester has at least one hydroxyl group associated with its aliphatic alcohol residue, and (3) mixtures of the monoesters and diesters.